FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Keytruda Plus Chemo Approved for Cervical Cancer

[ Price : $8.95]

FDA approves Mercks Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for patients with pers...

Some Class 1 Devices Exempt from UDI

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Unique Device Identification: Policy Reg...

Guide on Drug Continuous Manufacturing

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Q13 Continuous Manufacturing of Drug Substances and Drug Pr...

Revance Therapeutics FDA-483 Released

[ Price : $8.95]

FDA releases the FDA-483 with five inspection observations issued following an inspection at Revance Therapeutics.

Otsuka/H. Lundbeck sNDA for Rexulti in Adolescents

[ Price : $8.95]

FDA accepts for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating...

Embozene Breakthrough for Knee Osteoarthritis

[ Price : $8.95]

FDA grants Varian a breakthrough device designation for its Embozene microspheres for genicular artery embolization in treating sy...

FDA Posts Guide on Drug Continuous Manufacturing

[ Price : $8.95]

FDA posts a draft guidance entitled Continuous Manufacturing of Drug Substances and Drug Products Q13.

Panel to Review Pfizer Covid Vaccine in Kids

[ Price : $8.95]

Federal Register notice: FDA announces a 10/26 Vaccines and Related Biological Products Advisory Committee meeting to review and d...

FDA Changing Isotretinoin iPLEDGE REMS Requirements

[ Price : $8.95]

FDA approves changes to the isotretinoin iPLEDGE REMS.

3 Hand Sanitizer Guidances Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws three guidance documents on hand sanitizer products because consumers and healthcare person...